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Stem cells hold such huge promise in the treatment of many diseases. Here is an article about how they may work in fighting HIV. The Bush administration had placed severe limits in how stem cells could be used in research; these limits were just recently lifted by Obama, something that has excited scientists and those of us living with chronic diseases.

UCLA researchers demonstrate that stem cells can be engineered to kill HIV

Innovative strategy could be effective against other chronic viral diseases.

Researchers from the UCLA AIDS Institute and colleagues have for the first time demonstrated that human blood stem cells can be engineered into cells that can target and kill HIV-infected cells — a process that potentially could be used against a range of chronic viral diseases.

The study, published Dec. 7 in the-peer reviewed online journal PLoS ONE, provides proof-of-principle — that is, a demonstration of feasibility — that human stem cells can be engineered into the equivalent of a genetic vaccine.

"We have demonstrated in this proof-of-principle study that this type of approach can be used to engineer the human immune system, particularly the T-cell response, to specifically target HIV-infected cells," said lead investigator Scott G. Kitchen, assistant professor of medicine in the division of hematology and oncology at the David Geffen School of Medicine at UCLA and a member of the UCLA AIDS Institute. "These studies lay the foundation for further therapeutic development that involves restoring damaged or defective immune responses toward a variety of viruses that cause chronic disease, or even different types of tumors."

Taking CD8 cytotoxic T lymphocytes — the "killer" T cells that help fight infection — from an HIV-infected individual, the researchers identified the molecule known as the T-cell receptor, which guides the T cell in recognizing and killing HIV-infected cells. These cells, while able to destroy HIV-infected cells, do not exist in enough quantities to clear the virus from the body. So the researchers cloned the receptor and genetically engineered human blood stem cells, then placed the stem cells into human thymus tissue that had been implanted in mice, allowing them to study the reaction in a living organism.

The engineered stem cells developed into a large population of mature, multifunctional HIV-specific CD8 cells that could specifically target cells containing HIV proteins. The researchers also found that HIV-specific T-cell receptors have to be matched to an individual in much the same way that an organ is matched to a transplant patient.

The next step is to test this strategy in a more advanced model to determine if it would work in the human body, said co-author Jerome A. Zack, UCLA professor of medicine in the division of hematology and oncology and associate director of the UCLA AIDS Institute. The researchers also hope to expand the range of viruses against which this approach could be used.

But the results of the study suggest that this strategy could be an effective weapon in the fight against AIDS and other viral diseases.

"This approach could be used to combat a variety of chronic viral diseases," said Zack, who is also a professor of microbiology, immunology and molecular genetics. "It's like a genetic vaccine."

In addition to Kitchen and Zack, investigators included Michael Bennett, Zoran Galic, Joanne Kim, Qing Xu, Alan Young, Alexis Lieberman, Hwee Ng and Otto Yang, all of UCLA, and Aviva Joseph and Harris Goldstein of the Albert Einstein College of Medicine in New York.

The California Institute for Regenerative Medicine (CIRM) and the UCLA Center for AIDS Research funded this study.By Enrique Rivero

whats done is done now it would'nt help us if we try to find out "why" this and why that !, the reserch is already frustrating by it self,add on top of the that the tiger that bit the monkey and infected it with hiv

Alan Trounson, the president of the California Institute of Regenerative Medicine said this re: HIV/AIDS and stem cells:

He said his US-based institute, together with Britain and Canada, had recently funded $230 million of research - including a project that could basically eliminate HIV in patients already carrying the virus.

''We know that in general it works, now we just want to make sure we can do it effectively, on a large scale and at a low cost,'' he said.

Alan Trounson, the president of the California Institute of Regenerative Medicine said this re: HIV/AIDS and stem cells:

He said his US-based institute, together with Britain and Canada, had recently funded $230 million of research - including a project that could basically eliminate HIV in patients already carrying the virus.

''We know that in general it works, now we just want to make sure we can do it effectively, on a large scale and at a low cost,'' he said.

Three UCLA Broad Stem Cell Research Center scientists, Drs. Don Kohn, Irvin Chen, and Dennis Slamon, were awarded CIRM (Proposition 71) grants totaling $49.2 million to take leading-edge stem cell science from the laboratory and translate it into new therapies for such devastating diseases as sickle cell, HIV/AIDS and brain, ovarian and colorectal cancers within four years.

Three UCLA Broad Stem Cell Research Center scientists, Drs. Don Kohn, Irvin Chen, and Dennis Slamon, were awarded CIRM (Proposition 71) grants totaling $49.2 million to take leading-edge stem cell science from the laboratory and translate it into new therapies for such devastating diseases as sickle cell, HIV/AIDS and brain, ovarian and colorectal cancers within four years.

I hope this vaccine will not require excellent performance of CD4 cells and cellular immunity pathway (normal to high IL-4 and IL-10). We, HIV positive people, many times take vaccines that are not effective at all because our cellular immune system is not functioning normally (yes, even cellular immunity is needed for humoral [Bcell, plasma-cell, antibody] immunity).

I hope this vaccine will not require excellent performance of CD4 cells and cellular immunity pathway (normal to high IL-4 and IL-10). We, HIV positive people, many times take vaccines that are not effective at all because our cellular immune system is not functioning normally (yes, even cellular immunity is needed for humoral [Bcell, plasma-cell, antibody] immunity).

But, this approach MAY be ok since it puts stress on CD8 cells.

Since this involves cloning I would imagine that one's level of cellular immunity would not be a factor. The poz.com piece, linked above, mentions the possible challenges that are expected.

As I feared we need to wait at least another 14 years to see if this studies will bring benefits and until that time we will need to continue taking the current medicines. The grant was made with the expectation to file and IND application for beginning clinical trials. This means that phase I trials will not start until 2013 and then last for another 8 to 10 years for completition. Indeed it was too good to be true having a treatment available in only 4 years.

As I feared we need to wait at least another 14 years to see if this studies will bring benefits and until that time we will need to continue taking the current medicines. The grant was made with the expectation to file and IND application for beginning clinical trials. This means that phase I trials will not start until 2013 and then last for another 8 to 10 years for completition. Indeed it was too good to be true having a treatment available in only 4 years.

The applicant proposes a preclinical research and development plan that includes all activities leading to the Investigational New Drug (IND) filing for use of gene-modified autologous HSCs in AIDS patients already undergoing HSC transplantation for lymphoma. The proposed plan consists of 4 coordinated phases addressing process development and regulatory requirements for the proposed cell-based investigational product. Phase I includes optimizing vector transduction conditions and functional evaluation of hematopoietic potential and HIV resistance in vivo. Parallel studies with a backup good manufacturing practice (GMP)-grade viral vector will be performed for comparison. In Phase II the applicants propose to develop clinical scale cGMP cell product manufacture and release methodologies. Metrics used to evaluate the process include process yields, safety profile (in vitro and in vivo) and functional testing (in vivo). Phase III consists of validation studies that include full-scale manufacturing runs. Phase IV runs concurrently with Phase I-III and includes carcinogenicity studies and activities such as pre- IND FDA meeting, and reviews by the RAC (Recombinant DNA Advisory Committee of the Office of Biotechnology Activities of the National Institutes of Health) amongst others. The filing of an IND is scheduled in the 4th year of the grant.

The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.

There's indeed confusion and many missleading informations

« Last Edit: December 08, 2009, 06:55:35 PM by xman »

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The grant you are citing is specifically for a study for those with HIV who also have lymphoma.

Sangamo already has a clinical trial ongoing that is looking at ZFN on HIV by blocking the CCR5, which is the exact same thing that is described in what you cite (except for the lymphoma part). They already have an IND on blocking CCR5 on HIV using ZFN.

I am saying that Sangamo already has a clinical trial ongoing that is looking at ZFN on HIV by blocking the CCR5, which is the exact same thing that is described in what you cite. They already have an IND on ZFN for HIV using CCR5.

Sangamo received the grant in October 2009. They began the trial in the beginning of 2009 so before receiving the grant. I can't understand why the grant refers to an IND application in the 4th year if Sangamo still is in a phase I trial. Maybe I'm splitting hairs but it's confusing.

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Alan Trounson, the president of the California Institute of Regenerative Medicine said this re: HIV/AIDS and stem cells:

He said his US-based institute, together with Britain and Canada, had recently funded $230 million of research - including a project that could basically eliminate HIV in patients already carrying the virus.

''We know that in general it works, now we just want to make sure we can do it effectively, on a large scale and at a low cost,'' he said.

"This group proposes to treat HIV/AIDS using an RNA interference approach to modify the patient’s blood-forming stem celis. When transplanted back, those cells will produce T cells that are resistant to HIV infection"

and a second grant (not related to Calimmune);

Grant #DR1-01490

"This group proposes to treat HIV/AiDS using a gene therapy approach to modify the patient’s blood-forming stem celis. When transplanted back, those cells will produce T cells that are resistant to HIV infection."

Things are definitely happening right now. The race is on!

I also found it amusing that Canada is a major funding contributor as it truly makes sense considering the Canadian government alone funds the bulk of medicare in Canada. As such, Canada has a huge incentive to fund such stem cell therapies. From a Big Pharm perspective, the Canadian government acts a massive single customer which has universal medicare program that can very effectively "rollout" these stem cell therapies in an organized and universal way.

As I feared we need to wait at least another 14 years to see if this studies will bring benefits and until that time we will need to continue taking the current medicines.

Oh, god, if the average life span for an HIVer is 22 year, and he has already take the medication for 8 year, then 22-8=14, it means when the vaccine comes out, he is already a dead corpse.

Why it need to take so long? Can we volutary choose to use the drug even if it does not pass all the clinical trial? I don't want to die (because of HIV, hepatitis or heart attack cause by HAART) just because the reachable medication need to past the clinical trial.

NO! I refuse to die just because government say "it is not ready yet!!!"

Can we volutary choose to use the drug even if it does not pass all the clinical trial? I don't want to die (because of HIV, hepatitis or heart attack cause by HAART) just because the reachable medication need to past the clinical trial.

NO! I refuse to die just because government say "it is not ready yet!!!"

what do you think clinical trials are all about anyway? Partially, they are made up of people voluntarily taking a drug that is believed, backed by research, to have a beneficial effect and trying to actually prove that beneficial effect. Either join one of those clinical trials and take the risks and consequences of that decision, or sit back and wait for the science to prove these meds actually work.

If you want to take just any old thing that someone says will cure HIV, just google HIV cure up cause there are plenty of scammers out there that will take your money and let you die. I'm sorry that science moves cautiously towards it's goals. That's just how reality is when you're trying to understand the science to create the chemicals to make the effect that you'd like to have. Just remember that there are people with other diseases that have been waiting for their cure too - and some longer than us pozzies. Alzheimer's, diabetes, MS, etc. The list is endless of diseases that can kill people that science is working towards finding the cure.

The process itself has already been sped up through the years. So much, that it already makes me wonder about what long-term effects some people will be in store for in the future from the newer meds on the market? Rushed through as they were, we'll never known until the problems start appearing in another 10 yrs or so. As I wonder how many people would have taken Zerit knowing it's long-term side effects; I have to wonder how many people might regret taking Atripla somewhere down the line?

Until an actual cure is developed, all you can do is what plenty of people have been doing for years - take the meds now, hope that doesn't cause even worse problems in the future, while they keep you alive through today and into tomorrow when the "cure" might eventually be found. Or, as I suggested, you can go join a trial and perhaps help the scientists reach that goal sooner.

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leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

Can we volutary choose to use the drug even if it does not pass all the clinical trial?

There's salvage therapy. If you have no more other treatment options due to resistance or side effects which is quite rare you're allowed to use any alternative treatment or therapy even if not approved by the FDA.

I don't want to die (because of HIV, hepatitis or heart attack cause by HAART) just because the reachable medication need to past the clinical trial.

There are no doctors that would ever permit you to die even if you pay them. It would be illegal so you don't have to worry about this. That is why you routinely make exams to see if everything works fine. Remember that their job is to treat you and every option would be used to keep you alive.

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Apparently Irvin Chen's team is ready for human clinical trials, according to what he is quoted as saying. He also said that, in theory at least, the therapy is expected to be a single treatment:

"If you can artificially knock out CCR5, you can make the cells resistant to HIV," Chen said. "We thought we could use RNA interference — and we proved in preclinical and animal models that it works. Now we are ready to test this theory in human clinical trials."

In effect, researchers will be creating a new blood system that carries the RNA interference therapy in it. Chen said that, in theory, an effective stem cell RNA interference therapy will require only a single treatment, as opposed to the current lifetime administration of expensive anti-HIV-1 drugs, which often result in serious side effects.

"The goal of lifelong control or even, potentially, eradication of HIV via a stem cell therapy will not be straightforward," Chen said. "We have assembled the combined AIDS and stem cell expertise of investigators from four California academic institutions, as well as a corporate partner and a host of world-renowned advisers. Each will contribute unique expertise toward the development of a safe and efficacious therapeutic path into patients."

Independent reviewers of Chen's grant said the proposal was very strong and that "the resources and investigators are outstanding and the team is superb, both scientifically and in therapy development."

Apparently Irvin Chen's team is ready for clinical trials on humans, according to what he is quoted as saying.

They are ready but aren't there yet. They didn't even request an IND application. I guess this will not start until the end of 2010. Also the trials are expected to be very long. Since no stem cell therapies were ever made for HIV and to have a reliable safety profile of this approach, phase I could take 5 years at least meaning that there entire trial process would be very time consuming. Even if they prove that the approach seems to work, observational studies to see if the virus comes back will take 3 years as applied to the Berlin patient who after 2 years post transplantation seems free of virus.

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This is a succinct overview of the status of research using stem cells:

It was eight years in coming — which felt like eons to some researchers — but on March 9, President Obama rescinded his predecessor's Executive Order prohibiting the use of federal money to fund research on stem cells. A congressional law still prevents scientists from using government funds to create new lines of embryonic stem cells, which can develop into any of the body's tissues, but at least scientists are now free to use that money to study the hundreds of stem-cell lines already in existence. Before embarking on such research, however, scientists had to wait for a working group at the National Institutes of Health to vet the stem-cell lines and ensure that they were generated responsibly, according to stringent ethical and scientific principles. In December, the first lines to pass this test became available.

And this discovery is important because it's a very strong indication that iPS stem cells, which have no restrictions, could work just as well as embryonic stem cells:

The birth of yet another laboratory mouse is hardly worth noting — unless the furry creature is the first to be developed from stem cells that do not involve embryonic cells. That deserves to be called a breakthrough. The new pups, whose creation in two separate labs in China was announced in July, were the first to be bred from induced pluripotent stem (iPS) cells. These are adult cells (usually skin cells) that scientists reprogram back to their embryonic state by introducing four genes. The reprogrammed stem cells are then programmed again to develop into mice, a feat that has been accomplished before only using embryonic stem cells. Breeding an entire mouse that is itself capable of reproducing — as the mice did in one of the Chinese labs — is a strong sign that iPS cells may be as useful as embryonic stem cells for a potential source of treatments for disease, scientists said.

So despite 1 year on HAART (and still an out of range level of CD8), my immune system is still recovering.

CD8 means killer cells, but it can also means body activation.

As such, the key point of this research must not be to just produce CD8 but to produce"engineered stem cells developed into a large population of mature, multifunctional HIV-specific CD8 cells that could specifically target cells containing HIV proteins."

The keyword "specific" here is very important. Without it, this research won't be interesting. Because many HIV+ are already over producing CD8.